Moorpark, CA – 10 March 2018 – Jamie Colgin, President of Colgin Consulting, Inc. and Principal Consultant, Validant, will be a featured expert panelist for the Food and Drug Law Institute’s (FDLI) live webinar entitled “Data Integrity: FDA Enforcement and Risk-Reduction Considerations.” The webinar takes place on Tuesday 13 March 2018 from 2:00 to 3:30… [Read More…]
3 Tips for EDC Audit Trails
What follows is more or less a transcript of my presentation at the joint annual meeting of the San Diego Regulatory Affairs Network and the Orange County Regulatory Affairs Discussion Group on 19 Nov 2014. The 3 tips? 1) Use good password reset practices; 2) Don’t allow queries to fire until data are saved; and 3)… [Read More…]
Invisible Ink in GLP and GCP Research
What follows is more or less a transcript of my presentation at the annual meeting of the Pacific Region Chapter of the Society of Quality Assurance on 6 Nov 2014. The conclusion? A proposal that the same requirements for data integrity apply to GLP, GCP, and GMP data and that there is no regulatory basis for claiming… [Read More…]
How Do I Apply ALCOA To E-Records?
It’s easier than you think! Let’s Start with a paper record example Explore how to apply ALCOA to electronic records Point out 3 warning signs on the trail to data integrity ALCOA in the paper world ALCOA defines the generally accepted standard for GLP and GCP data quality and data integrity. Let’s use paper CRFs at a clinical investigator’s… [Read More…]
